Focus : Disclosure of Investigators’ Recruitment Performance in Multicenter Clinical Trials: A Further Step for Research Transparency

Focus : Disclosure of Investigators’ Recruitment Performance in Multicenter Clinical Trials: A Further Step for Research Transparency

Source: Disclosure of Investigators’ Recruitment Performance in Multicenter Clinical Trials: A Further Step for Research Transparency. Rafael Dal-Ré (rfdalre@gmail.com; rdal-re@fpmaragall.org), David Moher, Christian Gluud, Shaun Treweek, Jacques Demotes-Mainard, Xavier Carné. PLoS Med 8(12): e1001149

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http://www.plosmedicine.org/article/fetchObjectAttachment.action?uri=info%3Adoi%2F10.1371%2Fjournal.pmed.1001149&representation=PDF

Summary Points

            ● Many clinical trials are terminated before reaching the sample size needed to test the trials' hypotheses owing to poor recruitment.

            ● Registries, such as ClinicalTrials.gov, provide information on the main features of a multicenter clinical trial (MCT) to the general public.

            ● Site investigators are key to the success of MCTs; however, information on their recruitment performance is not publicly available.

            ● We propose that sponsors should disclose the recruitment targets of all site investigators on ClinicalTrials.gov before a trial starts as well as their final recruitment. Information on issues that could have affected recruitment should also be provided.

            ● This information will be of interest to different stakeholders such as patient organizations, sponsors, and MCT networks.

            ● Disclosing all site investigators' recruitment figures could prompt queries to the sponsor from the scientific community about regional subgroup analyses, to assess if ethnic or standard-of-care differences have an impact on treatment outcomes.